Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Young Adults

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    Alice Bertaina
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Updated on 19 February 2024
See if I qualify
cancer
cardiovascular disease
renal function
direct bilirubin
ejection fraction
immunosuppression
hla-a
graft versus host disease
hematologic malignancy
arrhythmia
congestive heart failure
alt/ast
hla-drb1

Summary

The purpose of the CliniMACS TCR-Biotin System and CliniMACS CD19 is to improve the safety and efficacy of allogeneic HLA-partially matched related or unrelated donors HSCT when no matched donors are available, to treat malignant and nonmalignant disorders for which HSCT is the recommended best available therapy. Initially this device will be used in a single-center, open-label, single-arm, phase II clinical trial to evaluate the efficacy of haploidentical PBSC grafts depleted of TCR/+ and CD19+ cells using the CliniMACS TCR/CD19 System in children and adults with hematological and non-hematological malignancies.

Details
Condition Blood disorder
Age 1years - 60years
Treatment Allogeneic Stem Cell Transplant, CliniMACS TCR α/β Reagent Kit and CliniMACS CD19
Clinical Study IdentifierNCT04249830
SponsorAlice Bertaina
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age < 60 years and > 1 month
Life expectancy > 10 weeks
Patients deemed eligible for allogeneic HSCT per institutional guidelines
Patients with life-threatening hematological malignancies and non-malignant disorders that could benfit from HSCT
A minimum genotypic identical match of 5/10 is required
The donor and recipient must be identical, as determined by high resolution typing, in at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and HLA-DRB1
Lansky/Karnofsky score > 50
Signed written informed consent
Male and female subjects of childbearing potential must agree to use an effective means of birth control to avoid pregnancy throughout the transplant procedure, while on immunosuppression, and if the subject experiences any chronic GvHD

Exclusion Criteria

Pregnant or lactating females
Greater than Grade II acute GvHD or severe, unmanaged chronic extensive GvHD due to a previous allograft at the time of inclusion
Dysfunction of liver (ALT/AST > 10 times upper normal value, or direct bilirubin > 3 times upper normal value), or unmanageable dysfunction of renal function
Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction < 30%)
Current active infectious disease (including positive HIV serology or viral RNA)
Serious concurrent uncontrolled medical disorders
Lack of patient's/parents'/guardian's informed consent
Any severe concurrent disease which, in the judgement of the sponsor-investigator, would place the patient at increased risk during participation in the study
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cancer
cardiovascular disease
renal function
direct bilirubin
ejection fraction
immunosuppression
hla-a
graft versus host disease
hematologic malignancy
arrhythmia
congestive heart failure
alt/ast
hla-drb1

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